Sex and the Single Drug

The hunt for the first medical boost for female desire offers a case study in how drug makers are dealing with quality-of-life issues.

NATASHA SINGER

THERE’S been a lot of hype lately about an experimental drug to treat sexual disinterest in women, a difficulty formerly known as the “Not tonight, Honey, I have a headache” problem.

It turns out to be a polarizing issue.

In a Viagra-flooded culture, where men have access to little blue pills to quell performance anxiety, isn’t it only fair that women should have a sex-enhancement drug of their own? Or, is a woman’s desire so much more complicated and contextual than a man’s that it cannot be localized to a single anatomical deficiency suitable to pharmaceutical remedy? And, by the way, some women’s health advocates ask, why are we seeking to “fix” women when a lack of desire is often a side effect of another malady: the “men don’t know how to please their partners” disease? (There’s no pill for that.)

Right now, there isn’t a federally approved drug in the United States to treat female libido difficulties. But a novel female desire drug, called flibanserin, now under review by the Food and Drug Administration, has stirred up both proponents and detractors. (My colleague Duff Wilson has written in detail about the debate over the drug.)

Clinical trials sponsored by the drug’s maker, Boehringer Ingelheim, reported that pre-menopausal women on flibanserin experienced a small increase in satisfying sexual activity, compared with women taking a placebo. But a panel of independent medical experts, convened by the F.D.A. to vet the drug, voted that its small effect in heightening libido did not outweigh side effects like dizziness and nausea. Boehringer Ingelheim said in a statement that it was disappointed with the panel’s recommendations and would work with the F.D.A. to address the group’s questions.

In the meantime, the parabola of hype and deflation over the so-called pink Viagra illustrates the challenges that drug makers are likely to face as they expand further into quality-of-life issues like sex from more familiar and saturated chronic-problem categories like high cholesterol.

The market potential for quality-of-life issues seems enormous. A 2005 article in the journal Nature Reviews Drugs Discovery, for example, predicted that revenue for female sexual dysfunction treatments in the United States could exceed $4 billion annually “with only 15 percent of patients captured on therapy.”

All of this carries caveats, of course. Regulators and doctors tend to be less tolerant of side effects in quality-of-life drugs than they are in medicines intended to mitigate life-and-death diseases. Some industry critics, meanwhile, contend that in the quest to find new and treatable quality-of-life problems, drug makers are not so much identifying unmet needs as they are stoking existing social anxieties to weld to their medicines.

The hunt for the first medical boost for female desire or arousal offers an interesting case study.

Women naturally experience fluctuating levels of desire over the course of their lives. Lessened libido can be prompted by issues like depression, abuse, bad relationships or stress. In a subset of women, doctors say, sexual disinterest can cause significant personal distress, clinically classified as “hypoactive sexual desire disorder.” The question is whether its antidote is therapy, patience, relationship changes, pharmacology or a combination thereof.

Pharmaceutical companies once hoped that Viagra, or other impotence drugs that men take on an occasional basis to increase blood flow to the penis, would similarly bolster arousal in women.

“That didn’t go anywhere,” says Dr. R. Taylor Segraves, a professor of psychiatry at the School of Medicine at Case Western Reserve University in Cleveland, who specializes in sexual disorders. Unlike men, says Dr. Segraves, who is a consultant and investigator for Boehringer Ingelheim, women with difficulties in desire or arousal rarely complain of physical malfunctions.

“I think it was rather naïve on the part of pharmaceutical companies,” he says, “to think that sexuality in females is the same as in males.”

Next, some drug companies turned to hormones as a potential treatment. But in 2004, when an F.D.A. panel met to consider a testosterone patch to treat libido difficulties in women who had had their ovaries removed, the experts said they were concerned that the product might increase the risk of cancer and heart attacks.

Dr. Segraves says that in the absence of an F.D.A.-approved testosterone patch for female desire, some doctors prescribe male testosterone drugs in low doses for women. “How safe that is, I don’t think we have good long-term data,” he says.

The latest attempt, flibanserin, offers a third way to treat the female libido: brain chemicals. The drug was first developed as an antidepressant. The pills didn’t do much to combat depression, Dr. Segraves says, but Boehringer Ingelheim repurposed the product after women in depression studies reported experiencing increased sexual interest.

In North American studies of the drug in premenopausal women, patients using flibanserin reported an average of nearly one more satisfying sexual event per month — oral sex, say, or intercourse — than women taking a daily sugar pill.

Leonore Tiefer, a psychotherapist in Manhattan who specializes in sexual disorders, jokes that the pill’s apparently meager benefit amounts to an additional “three-quarters of an orgasm” a month.

But for women who previously had no satisfying sex at all, even a small increase might be significant.

The fact that drug makers have taken three different medical routes — the circulatory system, the endocrine system and the nervous system — may indicate that female desire is so complicated that an even more novel approach is required: treatment with multiple therapies.

Or it may indicate that some drug makers are simply trying to tailor a sexual difficulty to mesh well with how some of their drugs operate in the body, says Ray Moynihan, a frequent contributor to BMJ, formerly the British Medical Journal, and co-author of a forthcoming book called “Sex, Lies and Pharmaceuticals.”

“The disease seems designed to fit whatever pharmaceutical solution exists at the time,” says Mr. Moynihan. “If it is a disease.”

BUT the hurdles for a female libido drug may be getting higher.

The next edition of the Diagnostic and Statistical Manual of Mental Disorders, a psychiatry reference book, proposes to do away with the old diagnosis of hypoactive sexual desire disorder. In its stead, a new diagnosis would more narrowly define reduced libido as a lack of sexual interest over at least six months, as well as other criteria — a potential change that could create a higher threshold for prescribing drug therapy.

“I think it should be fairly tough to make that diagnosis because, if we have a drug, people are going to be throwing it around right and left,” says Dr. Nada L. Stotland, a psychiatry professor at Rush Medical College in Chicago. “I think it deserves considerably more investigation.”

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